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Completed

NCT Number: NCT03928496

Abobotulinumtoxina Efficacy in Post-Traumatic Headache

This study will evaluate the efficacy of abobotulinumtoxina on Veterans with post-traumatic headache

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Key information

Conditions

Post-Traumatic Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Secondary Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

VA Greater Los Angeles Healthcare System

Los Angeles, California, 90073, United States

About this study

A significant proportion of headaches occur following head trauma, and therefore are referred to as post-traumatic headaches (PTH). Traumatic brain injury (TBI) is highly prevalent in the Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) population and consequently there has been a rise in PTH in the clinical setting at VA hospitals. Botulinum toxin type A (BoNT-A) has been shown to be effective in treating chronic migraine and chronic daily headache. It is therefore reasonable to predict that BoNT-A may also be effective in treating PTH. This study proposes that PTH and its associated symptoms may respond positively to BoNT-A treatment due to its similar pathophysiology and clinical resemblance to other headache disorders including tension type headache, typical migraine with or without aura, and chronic daily headache.

Study Design: Veterans with mild, moderate or severe brain injury with a headache developing within 7 days after head trauma and persisting greater than 3 months were recruited from the Veterans Affairs Greater Los Angeles Healthcare System. The study is a prospective, double-blind, randomized, placebo-controlled, cross-over trial.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • male or female
  • age 18-65
  • meets International Classification Headache Disorders II (ICHD-II) criteria for post-traumatic headache
  • average pain score of greater than 4/10 in severity on the numerical rating system
  • Rancho Los Amigos cognitive scale score greater than seven.

Exclusion criteria

  • Uncontrolled medical condition other than PTH
  • Severe additional chronic pain complaint which could not be distinguished from headache pain
  • pregnancy, breast feeding,
  • prior treatment with botulinum toxin within one year of enrollment
  • current substance abuse/dependence
  • medical condition that would increase risk of neuromuscular junction blockade with botulinum toxin (myasthenia gravis, Eaton Lambert, amyotrophic lateral sclerosis)
  • poorly controlled psychiatric
  • initiation of a new anti-depressant or anti-seizure medication within three months of enrolling in study
  • ongoing disability or litigation claim.

Treatment and study plan

AbobotulinumtoxinA

Drug

Subjects were injected with 0.1 ml (12.5 units of Abobotulinumtoxina) into 31 distinct muscle locations in the head and neck

Other names: Dysport

normal saline

Drug

Subjects were injected with 0.1 ml of preservative free normal saline into 31 distinct muscle locations in the head and neck

Primary outcomes

  1. Incidence of headaches from baseline

    Time frame: evaluation from time of injection until completion of 12 week follow-up

    Evaluation in weekly incidence of headaches from baseline based on headache diary or weekly phone follow-up

Secondary outcomes

  1. Intensity of headache pain

    Time frame: evaluation from time of injection until completion of 12 week follow-up

    Evaluation of pain intensity using score of headache on Numerical Rating Scale (NRS) over time. The NRS is an 11-point scale for patient self-reporting of pain with 0 being no pain and 10 being the most severe pain.

  2. Number of headache days per week

    Time frame: evaluation from time of injection until completion of 12 week follow-up

    Evaluation of the number of days a headache was present over each week

Sponsors and collaborators

Lead sponsor

VA Greater Los Angeles Healthcare System

Fed

Collaborators

  • Ipsen

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Apr 26, 2019
Registry last updated
Apr 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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